Abutment Macro Design and Peri-implant Tissues
Primary Purpose
Edentulous
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abutment with concave subcritical contour
Abutment with convex subcritical contour
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous focused on measuring dental implants
Eligibility Criteria
General Inclusion criteria:
- - Age more than 21 years
- Absence of relevant medical conditions
- Availability for 12 month follow-up
Specific Inclusion criteria:
- One missing tooth in the maxillary premolar region
- Presence of two adjacent teeth at the implant site
- Absence of periodontal disease
- Healed osseous architecture enough to receive an implant with a diameter of at least 3.5 mm and a sufficient amount of bone for placing implants with a length of at least 9 mm
General Exclusion Criteria:
- - Pregnancy at the screening visit.
- Smoking more than 10 cig/day
Specific Exclusion criteria:
- Adjacent implants
- Presence of periapical radiolucency at the adjacent teeth
- Missing adjacent teeth
Sites / Locations
- Nova Southeastern University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1
Group 2
Arm Description
Abutments with a concave configuration of the subcritical contour (emergence shape).
Abutments with convex configuration of the subcritical contour (emergence shape)
Outcomes
Primary Outcome Measures
Peri-implant mucosa margin position change
The primary outcome variable will be change on peri-implant mucosa margin position.
Secondary Outcome Measures
Full Information
NCT ID
NCT02546713
First Posted
September 9, 2015
Last Updated
April 12, 2022
Sponsor
Nova Southeastern University
Collaborators
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT02546713
Brief Title
Abutment Macro Design and Peri-implant Tissues
Official Title
The Influence of Abutment Macro-design on Peri-implant Tissue Dimensions for Guided Placed and Restored Implants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Southeastern University
Collaborators
Dentsply Sirona Implants and Consumables
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the effect of abutment macro-design on soft and hard tissue responses. This trial is designed as a randomized controlled clinical study in which two groups of fourteen partially edentulous patients will have as part of their treatment one implant placed in the maxillary premolar region.
Detailed Description
Implant placement and abutment design will be planned with a computer software for guided implant treatment (SIMPLANT). The surgical implant placement will be performed under manufacturer's protocol by placing the implant platform 1mm below the buccal aspect of the osteotomy (Koutouzis et al 2013). Virtually designed, permanent CAD-CAM fabricated abutments (ATLANTIS, DENTSPLY) with different configuration of the subcritical contour (emergence shape) will be connected to the implants and temporary crowns will be delivered.
Implants of the Group 1 will have permanent abutments with a concave configuration of the subcritical contour (emergence shape).
Implants of the Group 2 will have permanent abutments with a convex configuration of the subcritical contour (emergence shape).
The patients will be restored with single crowns 3 months following implant installation.
A randomization protocol will be produced from a computer-generated list for the distribution of subjects in the two treatment groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous
Keywords
dental implants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
Abutments with a concave configuration of the subcritical contour (emergence shape).
Arm Title
Group 2
Arm Type
Other
Arm Description
Abutments with convex configuration of the subcritical contour (emergence shape)
Intervention Type
Other
Intervention Name(s)
Abutment with concave subcritical contour
Intervention Description
Implants will be restored with abutments with concave configuration of the subcritical contour
Intervention Type
Other
Intervention Name(s)
Abutment with convex subcritical contour
Intervention Description
Implants will be restored with abutments with convex configuration of the subcritical contour
Primary Outcome Measure Information:
Title
Peri-implant mucosa margin position change
Description
The primary outcome variable will be change on peri-implant mucosa margin position.
Time Frame
Day 7-10 to the Day 360
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion criteria:
- Age more than 21 years
Absence of relevant medical conditions
Availability for 12 month follow-up
Specific Inclusion criteria:
One missing tooth in the maxillary premolar region
Presence of two adjacent teeth at the implant site
Absence of periodontal disease
Healed osseous architecture enough to receive an implant with a diameter of at least 3.5 mm and a sufficient amount of bone for placing implants with a length of at least 9 mm
General Exclusion Criteria:
- Pregnancy at the screening visit.
Smoking more than 10 cig/day
Specific Exclusion criteria:
Adjacent implants
Presence of periapical radiolucency at the adjacent teeth
Missing adjacent teeth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theofilos Koutouzis, DDS
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Southeastern University
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25216143
Citation
Koutouzis T, Neiva R, Nair M, Nonhoff J, Lundgren T. Cone beam computed tomographic evaluation of implants with platform-switched Morse taper connection with the implant-abutment interface at different levels in relation to the alveolar crest. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1157-63. doi: 10.11607/jomi.3411.
Results Reference
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PubMed Identifier
21542730
Citation
Koutouzis T, Koutouzis G, Tomasi C, Lundgren T. Immediate loading of implants placed with the osteotome technique: one-year prospective case series. J Periodontol. 2011 Nov;82(11):1556-62. doi: 10.1902/jop.2011.100751. Epub 2011 May 4.
Results Reference
background
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Abutment Macro Design and Peri-implant Tissues
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